US Drug Recall Register
Class II · Moderate risk Terminated Initiated Nov 2, 2016 (10 years ago)

Metformin Hydrochloride Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP

What was recalled

Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10

Recalling firm
Ascend Laboratories LLC
NDC code
67877-217-10
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0163-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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